Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children

To Compare Pharmacological and Non-Pharmacological Interventions (Use of Technology) For Alleviating Preoperative Anxiety In Children Undergoing General Anesthesia In A Tertiary Care Hospital Of Pakistan: A Randomized Controlled Trial.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05469412

Enrollment

Registered

2022-07-21

Start date

2023-03-20

Completion date

2024-04-01

Last updated

2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and Fear

Keywords

Preoperative Anxiety

Brief summary

The purpose of this study is to find out any beneficial effects of electronic devices over preoperative pharmacological intervention in the preoperative period.

Detailed description

Preparation for surgery with the induction of general anesthesia can be a stressful experience for a child. Preoperative anxiety can prolong induction of anesthesia and postoperative recovery, as well as increasing the risk of postoperative delirium, pain, and analgesic use. Pharmacological interventions are associated with increased cost to the hospital, potential surgical delay while waiting for the medication to take effect, and delayed discharge from the recovery room. Non-pharmacological modalities comprise education, behavioral techniques, parental presence at induction of anesthesia, and using technology including cellular phones and tablets/iPad, with each category including an array of effective strategies for reducing anxiety.

Interventions

DEVICEiPad®

Use of Technology.

DRUGMidazolam

Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

1. Children aged between 2 and 12 years old 2. ASA I and II 3. Informed consent signed by parents or legal guardians

Exclusion criteria

1. Previous exposure to surgery 2. Contraindication to midazolam 3. Patients with developmental delay 4. Patients with significant visual/hearing problems

Design outcomes

Primary

Measure	Time frame	Description
modified Yale Preoperative Anxiety Scale	Day 1	The instrument contains 27 items in 5 categories that indicate preoperative anxiety in children: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Scores range from 23.33 to 100, with higher values indicating higher anxiety.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026